MedDataX Logo

Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia

NCT ID: NCT01266759

Last Updated: 2010-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menorrhagia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Menorrhagia Vaginal ring Norethisterone Acetate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NuvaRing

For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.

Group Type EXPERIMENTAL

NuvaRing

Intervention Type DRUG

For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.

Norethisterone Acetate

Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment

Group Type ACTIVE_COMPARATOR

Norethisterone Acetate tablets - 5mg

Intervention Type DRUG

Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NuvaRing

For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.

Intervention Type DRUG

Norethisterone Acetate tablets - 5mg

Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception

Exclusion Criteria

* Menorrhagia of endocrine or systemic origin
* other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mansoura Faculty of Medicine, Mansoura University.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hatem Abu Hashim, MD MRCOG

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Waleed El-Sherbini, MD

Role: STUDY_DIRECTOR

Mansoura University Hospital

Mohamed Bazeed, MD

Role: STUDY_CHAIR

Mansoura University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16.

Reference Type BACKGROUND
PMID: 18635169 (View on PubMed)

Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.

Reference Type BACKGROUND
PMID: 15539438 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMH-245-C

Identifier Type: -

Identifier Source: secondary_id

MU-261z

Identifier Type: -

Identifier Source: org_study_id